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Part 2

Statistical Analysis and Design of Pharmaceutical Processes

Answer the questions below and return the solutions using the Canvas

portal. Provide the submitted solution as a single pdf file - do not sub-

mit multiple files. Work independently on the solutions. You can make

use of Excel or Matlab, but provide discussions of any worksheets or

scripts you embed in your pdf file. Provide a text discussion of your

results and answers.

Problem Statement

An experiment is conducted to determine the API concentration in a

batch reactor operated at three different temperatures by 2 different

operators. Three replicates are run at each temperature and operator

combination and the results are shown in the margin table.

Questions

1. Write the statistical model assuming two qualitative (categorical)

factors with interaction. Conduct an ANOVA to determine the

significance of each parameter using an x = 0.05. Justify any

assumptions in your model and ANOVA analysis.

2. Suppose the operators are blocks and temperature is qualitative.

Write the statistical model and conduct an analysis of the data.

3. Assume now replicates as well as operators are blocks where

replicates are ordered 1, 2, and 3 corresponding to their appear-

ance in each temperature/operator combination. Temperature

remains a qualitative factor. Conduct an analysis of the data.

4. How many error degrees of freedom would there be if operators

and replicates are considered as blocks and a quadratic polyno-

mial model is used for the temperature?

Fig: 1